Assessment of Gesture Accuracy of a Prosthesis Control System (ASCENT)

May 30, 2025 updated by: Phantom Neuro Inc.

Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System

The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78704
        • Phantom Neuro Inc. Operational Headquarters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Individuals 21 years in age and older
  2. Individuals with amputation of one or both arms at transradial level (applies to amputees only)
  3. Ability to follow study directions
  4. Willingness and ability to sign Informed Consent

Exclusion Criteria:

  1. Individuals with previously diagnosed muscle pathologies
  2. Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
  3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
  4. Cognitively impaired to follow study instructions
  5. Allergies to skin adhesive materials necessary for cutaneous electrode placement
  6. Excessive hair growth on arms and inability to shave off the hair for electrode placement
  7. Pregnant woman
  8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
  9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
All subjects will be instrumented with an electrode array on their forearms. The EMG signals detected by the electrodes will be fed into Phantom X hardware running the Phantom X algorithms. The algorithms will decode the EMGs signals and drive a desk mounted hand prosthesis.
Device: Non-invasive EMG band instrumentation
The sensed EMG signals from the subjects will be decoded by Phantom X algorithm and used to drive various gestures in a desk-mounted hand prosthesis
Other Names:
  • EMG prosthesis control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gesture accuracy
Time Frame: Acute visit (at most 3 hours)
Percentage of hand gestures accurately decoded by Phantom X algorithm
Acute visit (at most 3 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phantom Neuro Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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